'Torn records, ignoring consumer issues at Cadila's 2 plants'

Recounting specific norm violations in the two plants, USFDA said: "Our investigators found several plastic bags filled with paperwork and other scrapped items in the scrap yard.January 07, 2016, 06:00 IST

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New Delhi: Torn notebook with record of 'deficiencies', plastic bags filled with shreds of paperwork, failure to adequately investigate and address consumer complaints, are some of the major norm violations found by the USFDA at Cadila Healthcare's two plants in Gujarat.

As per the the warning letter sent by the USFDA over the two plants, the inspectors identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and deviations from CGMP for the manufacture of active pharmaceutical ingredients (APIs). "These violations and deviations cause your drugs to be adulterated, the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP," USFDA noted.

Recounting specific norm violations in the two plants, USFDA said: "Our investigators found several plastic bags filled with paperwork and other scrapped items in the scrap yard. One item was a torn notebook of deficiencies recorded during review of your batch manufacturing records." PTI

Only in India the healthcare financing is very small when compared to the financing by the other forces rather than the patient himself or herself paying out of pocket. Having 70-75% of the expenses as out-of-pocket, in my opinion, is not a right approach to managing healthcare in a country where the patients tend to sub-optimally purchase healthcare if he/she has to pay out-of-pocket.